Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

1. Royal College of Surgeons in IrelandColáiste Ríoga na Máinleá in Éirinn Aspects of the TRANSFoRm Project - HIQA, Dublin - 7th July 2011 Derek Corrigan 1, Christian Ohmann 2, Borislav D. Dimitrov 1, Tom Fahey 1 1 – RCSI, Ireland 2 - University of Dusseldorf, Germany

2. Overview • General overview and context for the TRANSFoRm project • Part A - Overview of TRANSFoRm work being done by RCSI • Part B – Core Services - Description of framework proposed to implement security and privacy in TRANSFoRm

3. The TRANSFoRm Project • “Translational Research and Patient Safety in Europe” –www.transformproject.eu • 5 Year FP7 EU funded research project – 1st year review complete - Antwerp • 17 International collaborating bodies including the HRB Centre for Primary Care Research (RCSI) • RCSI leading Work Package 4 – “Decision Rules and Evidence”

4. The TRANSFoRm Consortium

5. TRANSFoRm Goals • The underlying concept of TRANSFoRm is to develop a ‘rapid learning healthcare system’ driven by advanced computational infrastructure that can improve both patient safety and the conduct and volume of clinical research in Europe • Research trials are slow, manually intensive and costly • Huge potential in electronic sources of aggregated primary care data – e.g. GPRD in UK, Nivel in Netherlands, national disease registries • Bridging clinical research and primary care practice – dissemination of timely evidence based care

6. The TRANSFoRm Project SAFER CLINICAL PRACTICE MORE RESEARCH EVIDENCE TRANSFoRm -INTEGRATION -INTEROPERABILITY -SERVICES EPIDEMIOLOGICAL STUDIES AND RCTS KNOWLEDGE TRANSLATION

7. The TRANSFoRm Project • 3 sets of clinical use cases defined for implementing and validating TRANSFoRm approach: • Research use cases – electronic research trials • Genotype/Phenotype study in type II diabetes • Randomised control trial (RCT) in gastro-oesophageal reflux disease (GORD) • Patient safety use cases – clinical decision support • Chest pain, abdominal pain, dyspnoea (shortness of breath)

8. The TRANSFoRm Project PART A – RCSI work

9. The TRANSFoRm Project – My Background • Worked as a software developer for many years! • Completed Masters in Health Informatics with TCD in 2010 • Joined HRB Centre for Primary Care Research in 2010 to work on the TRANSFoRm project • Work package lead for WP4 – decision rules and evidence

10. WP 1 RESEARCH USE CASES WP 2 PATIENT SAFETY USE CASE WP8 DEMONSTRATION INDUSTRY CONTRACT RESEARCH ORG ACADEMIA WP9 DISSEMINATION WEBSITE PUBLICATION WORKSHOPS PROTOTYPES COLLABORATION INFRASTRUCTURE TECHNOLOGY PLATFORMS WP10 MANAGEMENT User requirements Development and Evaluation ICT WP7 SYSTEMS AND SERVICES FOR DATA INTEGRATION

11. TRANSFoRmServices 2 Distributed GP EHRs With Decision Support 1 CPR Repository 3 Research Study Designer Clinical Prediction Rules Service Study Criteria Design CP Rules Manager Find Eligible Patient CP Classifier 4 Research Study Management 5 CPR Data Mining and Analysis Recruit Eligible Patient CPR Analysis & Extraction Tool Study Data Management

12. An Example – CRB 65 Rule – Pneumonia Mortality Confusion, Respiratory Rate >= 30/min, BP : SBP<90 mm Hg or DSP <= 60 mm Hg, Age >= 65 years Rule Criteria 0 1 OR 2 3 OR 4 CRB Score Mortality Low Mortality Intermediate Mortality High Risk Likely Home Treatment Likely Hospital referral and assessment Urgent Hospital Decision

13. Define Study Eligibility Criteria – Electronic Primary Care Research Network (Epcrn)

14. Analyse CPR usage and Epidemiological study data • Huge potential evidence base in EHRs in primary care • May be used to amend an existing rule i.e. the inclusion of additional symptoms/signs identified by data analysis as potential diagnostic cues. E.g. In the case of CRB 65, add Urea> 7 mmol/l. to rule criteria • May be used to create new CPR’s based on new diagnostic cue combinations • Evidence base becomes “self-learning” and adds or improves the list of CPR’s used to suggest potential diagnoses to a GP

15. How can this improve Patient Safety? • Diagnostic error is the major threat to patient safety in the context of the primary care setting • TRANSFoRm uses CPRs to broaden the evidence base considered by GPs to support inclusion / exclusion of diagnostic hypotheses for any particular case – not just previous GP case history • By implication, decreasing the possibility of diagnostic error will improve patient safety • Bridges the gap between implementing evidence based care research in the primary care setting

16. RCSI work to date – key elements

17. RCSI work to date – clinical evidence models

18. RCSI work to date – ontology development

19. The TRANSFoRm Project PART B –Core services

20. Common core services for TRANSFoRm • Confidentiality and privacy framework • Vocabulary services – how to manage different vocabulary schemes – e.g. SNOMED, ICPC2 • Provenance service – not just the “who” and “when” but the “why” – more than audit • Security model – Stephen Farrell (TCD)

21. Vocabulary services vocabulary service

22. Confidentiality and Privacy • Confidentiality and privacy are huge challenges for TRANSFoRm • Work done by Professor Christian Ohmann (WP3) and his group from the University of Dusseldorf to: • review the regulatory context for electronic clinical research systems • review the confidentiality and privacy context around EU legislation as applicable to TRANSFoRm • describe formal concepts abstracted from these contexts that can be used to describe a privacy and confidentiality framework suitable for TRANSFoRm

23. Regulatory context • Background: • currently no recognized (industry) standard for specific CDMS (clinical trial data management system) requirements available • lack of European guidance in the field of software and electronic records • use of electronic source data is becoming increasingly prevalent, current regulatory framework still focused on paper documents

24. Confidentiality and data privacy - EU legislative context Background: • divergent implementation of EU Directive 95/46/EC in the member states • access to health data in the EU hampered by fragmented legal framework, inconsistency in interpretation of regulations and variable guidance • existing frameworks largely limited in scope, target and application areas • different need for TRANSFoRm

25. Confidentiality and data privacy framework – development methodology Methods: • exploration of legal requirements and access policies • extraction of privacy principles (non-formal) definition of core formal concepts - zones/subzones, privacy filters and data linkers, actors and roles • development of a formal description of the framework based on structural analysis/data flow diagrams • application of the formal description to research scenarios and TRANSFoRm clinical use cases

26. Confidentiality and data privacy framework – key concepts Results: Formal description of theframework

27. Confidentiality and data privacy framework Care zone Non-care zone pseudonymousdata(e.g. cohortstudy, clinicaltrial DB, primarycare DB) directlyidentifiabledata (e.g. EHR) Subzone Subzone Research zone Research data (coded) anonymousdata (data needed forresearch project)

28. Confidentiality and data privacy framework Data bases in the non-care zone (example Netherlands): health care insurers data base about medical consumption (directly identifiable by insurer) LINH (Netherlands Information Network of General Practice) (coded indirectly identifiable) National cancer registry (indirectly identifiable) death registry at the Statistic Netherlands (directly identifiable by Statistic Netherlands)

29. Confidentiality and data privacy framework Results: Notation fordatatransfer, functions and actions

30. Confidentiality and data privacy framework - use case development counts of patients with a defined pattern find patients for clinical research select patients for research question extract information of selected patients linkage of data Results: Subcasesrepresented in theframework

31. Confidentiality and data privacy framework – use case example Results: Subcase 2 – Find patients for clinical research

32. Confidentiality and data privacy framework Results: Subcase 2 – Find patientsforclinicalresearch(different options) identificationoftrialpatientsbytreatmentphysicianwithintreatmentcontext identificationoftrialpatientsby extra staffactingforthetreatingphysician identificationoftrialpatients in non-caredatabases(e.g.researchdatabase, register) identificationoftrialpatients in careor non-caredatabasewiththepossibility to identifypatientsbytheresearcher

33. Confidentiality and data privacy framework Results: Subcase 2.1 – Find patients for clinical research

34. Confidentiality and data privacy framework Results: Subcase 2 - Find patientsforclinicalresearch 1: bytreatingphysicianin care-zone 3: in non-caredatabase

35. Confidentiality and data privacy framework Results: Subcase 5 – Linkage of databases Linkage of database in thecarezonewithdatabase in the non-carezone. Researcher isprovidedwithpseudonymized (orcoded) anonymousdataorfullyanonymizeddataaccording to researchquestion and authorisation

36. Confidentiality and data privacy framework Research scenarioforusecase GORD associationbetween PPI consumingandtheincidenceofadenocarcinoma Twodatabases in the same subzone of the non-carezone(e.g. cancerregistry, civicregistry)arelinkedbyTrusted Third Party (TTP). Thisdatabaselinkedbynew TTP withprimaryhealthcareresearchdatabase after passing a privacy filter

37. To summarise • Ambitious project with substantial Irish involvement • Privacy Framework provides conceptual language to define and discuss the issues specific to e-research using consistent terms • Conceptualisation of TRANSFoRm now moving into development and implementation • Technical challenges and solutions will now be the focus • Confidentiality and Privacy Framework was well received by EU review panel and encouraged dissemination of its contents

38. Thank You derekcorrigan@rcsi.ie Discuss!